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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208969
Company: AMPHASTAR PHARMS INC

Products on NDA 208969

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REXTOVY	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208969

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208969Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/208969Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2026	SUPPL-2	Efficacy-Rx To OTC Switch	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208969s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208969s002ltr.pdf
06/29/2023	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208969Orig1s001ltr.pdf

Labels for NDA 208969

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2026	SUPPL-2	Efficacy-Rx To OTC Switch	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208969s002lbl.pdf
06/29/2023	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s001lbl.pdf
06/29/2023	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s001lbl.pdf
03/07/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

REXTOVY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 4MG/SPRAY

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	217992	AMNEAL
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	211951	PADAGIS ISRAEL
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	209522	TEVA PHARMS USA
NARCAN	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	208411	EMERGENT
REXTOVY	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	208969	AMPHASTAR PHARMS INC

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